Regulatory Affairs Specialist – CMC Small Molecules | Bengaluru, India | Full-Time
Company Overview:
Astellas’ Global Capability Centers (GCCs) in India, Poland, and Mexico are strategically designed to enhance operational efficiency, innovation, and access to talent across the pharmaceutical value chain. The GCCs enable Astellas to deliver high-quality medicines to patients globally while driving regulatory compliance, operational resilience, and sustainable growth.
Role Overview – Regulatory Affairs Specialist (CMC):
Astellas is seeking a Regulatory Affairs (RA) Specialist – CMC Small Molecules to support Chemistry, Manufacturing, and Controls (CMC) regulatory activities across drug development and marketed product lifecycles. The role involves preparing and coordinating CMC submissions, ensuring compliance with global regulations, and providing technical input for regulatory filings. This position requires close collaboration with Global Regulatory Affairs, Quality Assurance, Product Development, and Manufacturing teams.
Key Responsibilities:
Prepare, compile, and transmit CMC regulatory submissions according to project timelines, SOPs, and regulatory requirements.
Contribute to regulatory impact assessments for proposed CMC changes and monitor progress.
Ensure proper documentation, version control, and dossier management for CMC activities.
Support assigned products across IND/CTA, BLA/MAA submissions, post-approval variations, and responses to health authority queries.
Act as a deputy to the CMC RA Scientific Lead, supporting both development programs and commercial products.
Collect, interpret, archive, and share regulatory information for CMC submissions.
Apply scientific knowledge and regulatory expertise to ensure timely product approval, launch, and maintenance of market supply.
Conduct all activities with strict adherence to compliance, safety, and quality standards.
Collaborate with cross-functional teams and provide regulatory guidance to support project success.
Qualifications & Experience:
Education: Bachelor’s degree in Chemistry, Pharmacy, Chemical Engineering, Biology, Microbiology, Biochemistry, or a related scientific discipline (graduate degree preferred).
Experience: Minimum 3 years of relevant experience in CMC regulatory affairs, biologics/vaccine research, manufacturing, or quality assurance (1 year for graduate degree holders).
Strong ability to critically review scientific data and assess technical arguments.
Proficiency in English; additional language skills are an advantage.
Organizational and multitasking skills to manage multiple submissions and projects simultaneously.
Preferred Qualifications:
Experience with small molecule drug products.
Familiarity with CMC regulatory databases (e.g., Veeva Vault, TrackWise Digital).
Knowledge of FDA, EMA, ICH regulations and guidelines and ability to interpret them for regulatory submissions.
Location: Bengaluru, India (Hybrid / On-site as required)
Job Type: Full-Time, Permanent
Why Join Astellas:
Work with a global pharmaceutical leader driving innovation and patient impact.
Gain exposure to cross-functional CMC regulatory operations and global regulatory strategies.
Opportunity to develop in a dynamic, collaborative environment supporting product development and lifecycle management.
Astellas is committed to diversity, equity, and inclusion, providing equal opportunities for all candidates, including persons with disabilities and protected veterans.
Equal Opportunity Statement:
Astellas provides equal employment opportunities in all aspects of employment, including recruitment, hiring, training, promotion, and benefits, without regard to race, color, ancestry, religion, sex, national origin, disability, or veteran status.
For more information about Astellas and career opportunities, visit www.astellas.com.
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